December 2014/January 2015

Jo Huskey, 55, was implanted with a Gynecare TVT Obturator (TVT-O) transvaginal mesh device to treat stress urinary incontinence. The device, which consists of a polypropylene mesh tape, is implanted beneath the mid-portion of the urethra, forming a sling designed to keep the urethra in place when the patient coughs, laughs, or strains in other ways that put pressure on the bladder.

Soon after receiving the device, Huskey began experiencing pelvic pain, which worsened and became constant. Exploratory surgery revealed that the mesh had eroded into the surrounding tissue. She underwent surgery to explant the device, but her doctor was unable to remove all of the mesh. Huskey’s incontinence returned, and she suffers from permanent, constant pelvic and vaginal pain and pelvic muscle spasms. Her past medical expenses totaled about $100,000, and she may require additional treatment, mesh-removal surgery, or both.

Huskey and her husband sued Ethicon, Inc., the manufacturer of the device, and Ethicon’s parent company, Johnson & Johnson, alleging strict liability design defect, negligent design, and failure-to-warn claims. The plaintiffs asserted that the device was defective and negligently designed in that the mesh was made of polypropylene, which is not safe for use in the human body. The plaintiffs presented expert testimony that the material is prone to shrink and erode, leading to pelvic abscesses, injury to internal organs, severe pelvic pain, and sexual and urinary dysfunction, among other problems. The plaintiffs also alleged that the defendants failed to warn of the risks posed by the device.

The defendants argued that polypropylene was unavoidably unsafe and that product’s benefits outweighed its risks.

The jury found for the plaintiffs on all claims and awarded $3.27 million, including $2.5 million for future pain and suffering, mental anguish, disability, or loss of enjoyment of life; $470,000 for those damages in the past; $200,000 for loss of consortium; and $100,000 for past medical expenses. The defendants have filed a motion for a new trial.

Comment: The case is reportedly the first federal trial over Ethicon’s TVT-O device. There are reportedly more than 30,000 suits pending against Ethicon over its transvaginal mesh devices used to treat urinary incontinence and pelvic organ prolapse. In April 2014, a Texas jury awarded $1.2 million to another consumer injured by the same device, and in February 2013, a New Jersey jury awarded $11.11 million to a consumer injured by Ethicon’s Gynecare Prolift, designed to treat pelvic organ prolapse.

There are more than 70,000 suits pending against seven different mesh device manufacturers in multidistrict litigation consolidated in West Virginia federal court, and several thousand more suits pending in various state courts.